体外诊断试剂临床试验中执行EP09c统计分析的方法探讨OA

Objective To perform accurate and efficient statistical analysis of EP09c in clinical studies of in vitro diagnostic reagents(IVDR).Methods Bias quantification was performed on the difference plot using MedCalc.Bias quantification was conducted on the scatter plot using regression modeling in SPSS and MedCalc.The difference plot and scatter plot were employed to corroborate the accuracy of the bias quantification results.Results Difference plots demonstrated that the low-concentration data of the working sample exhibited a constant standard deviation distribution with a bias of 0.10(0.09,0.28),while the high-concentration data conformed to a constant coefficient of variation distribution with a bias of-5.0%(median:-7.2%,1.5%)or-3.2%(Hodges-Lehmann median:-5.5%,-0.8%).Scatter plots confirmed that Passing&Bablok(P-B)regression and weighted least square(WLS)regression(weight xi1.4)were applicable to the data from the working sample,with the resulting regression equations being y=0.122+0.952x(R2=0.983)and y=0.269+0.977x(R2=0.981),respectively.Conclusions The results of bias quantification must be confirmed by difference plot and scatter plot,otherwise the correctness of the results cannot be assured.